Loading...
•
Dec 31, 2023
Xenon Pharmaceuticals Q4 2023 Earnings Report
Xenon Pharmaceuticals reported financial results for Q4 2023 and provided a corporate update.
Key Takeaways
Xenon Pharmaceuticals reported a net loss of $44.7 million for the fourth quarter of 2023. The company's cash and cash equivalents and marketable securities were $930.9 million as of December 31, 2023, expected to fund operations into 2027. The company is advancing its XEN1101 program in epilepsy and major depressive disorder.
XEN1101 Phase 3 epilepsy program continues to progress with X-TOLE2 and X-TOLE3 in focal onset seizures and X-ACKT in primary generalized tonic-clonic seizures; completion of patient enrollment in X-TOLE2 expected in late 2024 to early 2025.
Planned “end-of-Phase 2” meeting with the FDA in April to support the initiation of XEN1101 Phase 3 program in major depressive disorder in the second half of the year.
Strong financial position with approximately $930 million to fully support XEN1101 Phase 3 programs in epilepsy and major depressive disorder and expected cash runway into 2027.
The company continues to evaluate other neurological indications that present a potential fit for XEN1101’s novel mechanism and product profile.
Forward Guidance
Xenon anticipates patient enrollment in X-TOLE2 will be completed in late 2024 to early 2025. Xenon anticipates participating in an “end-of-Phase 2” meeting with the U.S. Food and Drug Administration in April to support the initiation of its late-stage XEN1101 clinical program in MDD, which will include three Phase 3 clinical trials, with the first Phase 3 study expected to initiate in the second half of 2024.
Positive Outlook
- Completion of patient enrollment in X-TOLE2 expected in late 2024 to early 2025.
- Planned “end-of-Phase 2” meeting with the FDA in April to support the initiation of XEN1101 Phase 3 program in major depressive disorder in the second half of the year.
- Strong financial position with approximately $930 million to fully support XEN1101 Phase 3 programs in epilepsy and major depressive disorder and expected cash runway into 2027.
- Advancing XEN1101 in major depressive disorder with plans to conduct an end-of-Phase 2 meeting with the FDA in April, and we expect to initiate our Phase 3 program in the second half of this year.
- We also continue to evaluate other neurological indications that present a potential fit for XEN1101’s novel mechanism and product profile.
Challenges Ahead
- Clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...